Mortality Remains High for STEMI Patients Complicated by Cardiogenic Shock
- Early reperfusion for STEMI patients complicated by cardiogenic shock results in lower mortality compared to prolonged reperfusion.
- Shorter onset-to-balloon (OTB) and door-to-balloon (DTB) times are recommended to improve patient survival.
- A shorter OTB was associated with longer overall survival in patients vs prolonged OTB (43.3% and 55.5%, respectively).
- Mortality rates for short vs long DTB in this study were 44.9% and 55.8%, respectively.
The significant reduction of in-hospital mortality related to ST-segment elevation acute myocardial infarction (STEMI) has been greatly attributed to the overwhelming adoption of primary percutaneous intervention (PCI). STEMI patients with cardiogenic shock (CS) tend to experience a higher mortality even after PCI and the implantation of mechanical circulatory support (MCS) devices.
A recent retrospective study published in European Heart Journal: Acute Cardiovascular Care assessed the mortality benefit, if any, of reperfusion via primary PCI for patients with STEMI complicated with CS of 466 patients enrolled in the Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) acute myocardial infarction (AMI) registry.
For the purpose of this study, CS was defined by the following Killip class IV criteria:
- Systolic blood pressure < 90 mmHg
- Vasoconstriction manifestations
To evaluate the primary outcome measure of all-cause mortality for these patients, researchers looked at the cumulative incidence of all-cause death in the patients with STEMI complicated by CS due to acute pump failure. The recorded incidence was as follows:
- 25.4% at 30 days
- 38.7% at 12 months
- 51.4% at five years
Researchers found that a shorter onset-to-balloon (OTB) time (< 3 hours) resulted in a significantly lower rate of death (Figure 1) compared to prolonged OTB (43.3% and 55.5%, respectively). There were similar findings between short and long door-to-balloon (DTB) time (44.9% vs 55.8%, respectively). Additionally, early reperfusion was associated with a lower rate of mortality.
While the patient population used in this study was relatively small (n=3942), the data shows mortality rates continue to remain high among patients with STEMI complicated with CS caused by acute pump failure. Implementing shorter OTB and DTB times, at least according to this study, may result in improved long-term survival.
- Kawaji T, Shiomi H, Morimoto T, et al. Long-term clinical outcomes in patients with ST-segment elevation acute myocardial infarction complicated by cardiogenic shock due to acute pump failure. Eur Heart J Acute Cardiovasc Care. 2016.
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
The Impella 2.5® and Impella CP® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
The Impella 2.5®, Impella CP®, Impella 5.0®, and Impella LD® Catheters, in conjunction with the Automated Impella Controller (collectively, “Impella® System Therapy”), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
The Impella Connect® transfers the video image of the screen on the Automated Impella® Controller to an authorized remote user. The transmitted image can be viewed by authorized remote users. The users can include the hospital’s clinicians, Abiomed local support staff, and Customer Support Center (CSC) team members.
Impella Connect Precautions
- Impella Connect is not intended to provide real-time information for monitoring patient status on the Automated Impella® Controller.
- During use of the Impella Connect, there will be a delay between when an image appears on the controller screen and when it is displayed at a remote viewing location.
- The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the controller’s alarms.
- During use of the Impella Connect, receipt of the displayed controller information is not confirmed by the Automated Impella® Controller, nor is the delivery of the displayed controller information to the authorized remote users guaranteed.
- The Impella Connect is not designed for use during transport.
- Radiated and conducted electromagnetic interference can affect the performance of the Impella Connect, causing a temporary loss of connectivity. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Any electromagnetic interference related to the Impella Connect will have no impact on any of the controller functional specifications.
- Portable and mobile RF communications equipment can affect medical electrical equipment.
Important Risk Information for Impella devices
The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*
* This condition is a contraindication for the cardiogenic shock indication only.
POTENTIAL ADVERSE EVENTS
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.